Integrity performance assessment of a closed system transfer device syringe adaptor lock as a terminal closure for Luer-Lock syringes.

Objectives: To investigate the container closure integrity of a closed system transfer device syringe adaptor lock in combination with disposable Luer-Lock syringes as the terminal closure device. The UK National Health Service (NHS) Pharmaceutical Quality Assurance Committee (PQAC) requires syringe integrity data for final storage devices of aseptic products such as chemotherapy drugs when prepared in advance and stored before use, as is standard practice for dose banded drugs. The assessment comprised both physical and microbial integrity testing of the combination closed system/Luer-Lock syringe containers at syringe sizes of 1 mL, 20 mL, and 50 mL.